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Tailored Transoral Incisionless Fundoplication (Tif) in the Treatment of Gerd: the Anatomic and Physiologic Basis for Reconstruction of the Esophagogastric Junction Using a Novel Approach
Blair a. Jobe1, Ger H. Koek2, Stefan J. Kraemer3, Barry P. Mcmahon4, Bart Witteman2, Flemming H. Gravesen5, Cedric S. Lorenzo*1, Robert W. O'Rourke1, Douglas a. Shumaker6, Michael M. Owens6, John G. Hunter1, Nicole Bouvy2
1Surgery, Oregon Health & Science University, Portland, OR; 2Surgery, Maastricht University Hospital, Maastricht, Netherlands; 3Endogastric Solutions, Inc., Redmond, WA; 4Medical Physics & Clinical Engineering, Adelaide & Meath Hospital and Trinity College, Dublin, Ireland; 5Visceral Biomechanics and Pain, Aalborg Hospital, Hobrovej, Denmark; 6West Hills Gastroenterology, Portland, OR
Objective: To determine the anatomic and physiologic basis & short-term efficacy of Transoral Incisionless Fundoplication (TIF) in GERD patients.
Methods: Nine patients with PPI-dependent GERD underwent TIF using the EsophyX™ device. TIF was performed endoscopically by enveloping the distal esophagus for 3 cm within the proximal stomach & securing this with transmural polypropylene fasteners. Pre- & post-TIF testing with pH, manometry, LES vector volume analysis, impedance planimetry, & upper endoscopy was performed. Mean time to follow-up was 3 months.
Results: Mean operative time was 60 minutes (range, 40-90). One patient developed pneumoperitoneum requiring needle aspiration. 8/9 patients were discharged within 24-hours post-TIF. All patients had complete symptomatic resolution of GERD & were off PPI at follow-up. LES cross-sectional area decreased in all patients post-TIF on impedance planimetry.
Conclusions: TIF results in the elimination of symptoms and normalization of distal esophageal pH exposure in patients with GERD. Evaluation of the post-procedure EGJ indicates restoration to normal anatomy & physiology.
| Endpoint | Pre-TIF | Post-TIF | p-value |
| Resting LES Pressure (mmHg) | 10.57 | 25.15 | 0.124 |
| LES Total/Abdominal Length (cm) | 2.8/1.5 | 3.6/2.6 | 0.075/0.13 |
| LES Vector Volume (mmHg2xmm) | 354 | 2904 | 0.015 |
| Mean Hill Classification, Range | II(I-IV) | I(all I) | 0.005 |
| Nipple Valve (%) | 0 | 89 | 0.02 |
| Hiatal Hernia (% and mean size) | 89/2 (1-3) | 0/0 | 0.004 |
| Esophagitis (%) | 57 | 0 | 0.025 |
| % time pH<4 in 24 hours | 8.5% (1.2-26.6) | 0.7%(0-1.6) | 0.019 |
